Prior art capping technology uses mechanical forming to crimp a metal seal onto a vial or other container for medicines. Normally, blades are used that reshape an edge of the seal under a top lip of the vial to form the seal. Such technology has several limitations. First, the prior art capping technology does not satisfy particle contamination parameters placed on the industry. As the metal seal is crimped in the prior art methods, particles of the metal seal may be released, and these particles may end up in the vial, resulting in the contamination of a medicine in the vial. As such, classified aseptic (and non-aseptic) conditions may be lost due to particle contamination generated by the prior art metal crimping and forming methods.
Secondly, the seal formed by the prior art method may sometimes be rotated upon the vial, which may be perceived by some in the industry as an inferior seal.
Further, either the container or the head on the machine must rotate during the sealing process, this often causes scratching, marring, or even breakage of the container. The extensive manual adjustments and the use of a metal blade against glass with poor tolerances also causes scratching, marring, or even breakage of the container. Some breakage of the container may not be apparent to post-process inspections. Glass that may have chipped inside the vial can potentially be extremely harmful to the patient. Another form of breakage, such as a hairline crack, may cause harm to the patient as well. For example, if a hairline crack allows outside atmosphere to interact with medicines that are oxygen sensitive, the medicine may be inactivated or even harmful when given to the patient.
Fourth, in addition to possibly harmful effects of damage to the container, current technology creates cosmetic side effects that internal and/or external quality departments, clinicians, and physicians often reject. For example, a vial that may have perfectly good product inside, but a cap that has been partially sliced by a blade, may often result in rejection by the physician or treating medical personnel, thereby losing that dosage and increasing the cost of the medicine.